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Sign in to claim this brandDIAGNOSTIC GRIFOLS SA
US
Last updated May 27, 2026
What DIAGNOSTIC GRIFOLS SA makes
The company manufactures in vitro diagnostic (IVD) devices for blood typing and antibody screening, including kits and reagents for Rh phenotype (CcDEe) and ABO/Rh(D)/Kell blood grouping via agglutination methods. Automated and semi-automated systems for washing and cleaning, as well as gel column agglutination centrifuges and column agglutination tests, are also part of its portfolio. Additional products include microplate/tube incubators, monospecific immunoglobulin G antihuman globulin (IgG AHG) antibodies, and diluent/wash solutions for blood group testing.
These devices are classified under FDA’s In Vitro Diagnostic Device Regulations, with most falling under Class I and Class II categories. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance. The company operates within the United States, adhering to applicable IVD regulatory standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Diagnostic Grifols SA manufacture?
Diagnostic Grifols SA specializes in in vitro diagnostic (IVD) devices primarily used for blood typing and antibody screening. Their portfolio includes blood grouping kits (such as ABO/Rh(D)/Kell and Rh phenotype CcDEe tests), column agglutination and gel column agglutination tests, automated/semi-automated washing and cleaning solutions, blood group/antibody screening analyzers, and accessories like incubators and monospecific immunoglobulin G antihuman globulin (IgG AHG) antibodies. These products are designed to support transfusion medicine and blood compatibility testing.
Where is Diagnostic Grifols SA based, and does this affect its regulatory compliance?
Diagnostic Grifols SA is based in the United States, which means its devices must comply with FDA’s In Vitro Diagnostic Device Regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, demonstrating adherence to U.S. regulatory requirements for traceability and authorization. Classification under FDA’s system ensures these devices meet safety and performance standards for their intended use.
Which regulatory registries or databases list Diagnostic Grifols SA’s devices?
Diagnostic Grifols SA’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and ensuring regulatory compliance of medical devices in the U.S., allowing healthcare providers and authorities to verify device details, classifications, and authorization status. Listing in the UDI database helps maintain transparency and traceability for these IVD products.
How are Diagnostic Grifols SA’s devices classified under FDA regulations?
Diagnostic Grifols SA’s devices are classified under FDA’s In Vitro Diagnostic Device Regulations as either Class I or Class II. Class I devices generally pose minimal risk and require general controls for authorization, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the strength of scientific evidence required to demonstrate performance.
What is the primary purpose of Diagnostic Grifols SA’s blood grouping and antibody screening devices?
The primary purpose of Diagnostic Grifols SA’s blood grouping and antibody screening devices is to ensure compatibility between donor blood and recipient patients, reducing the risk of adverse transfusion reactions. These devices detect blood type markers (such as ABO, Rh(D), Kell, and Rh phenotype CcDEe) and screen for antibodies in blood samples using agglutination or gel column methods. Accurate testing is critical for safe blood transfusions, organ transplants, and other medical procedures requiring blood compatibility.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- grifols.com
- —
- —
- [email protected]
- Phone
- (800)452-6877
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 463625602
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DG Gel 8 Rh Pheno | 210387 | FDA UDI | N/A | Unknown |
| DG Spin | 210363 | FDA UDI | Class II | Active |
| DG Gel 8 AB (x4) | 210386 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-e | 210124 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-e | 210227 | FDA UDI | N/A | Active |
| DG Gel 8 ABO/Rh+Kell | 210383 | FDA UDI | N/A | Unknown |
| DG Gel 8 Rh Pheno | 210387 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-AB | 210125 | FDA UDI | N/A | Unknown |
| DG Gel 8 A/B/D | 210384 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-C | 210121 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-IgG (Rabbit) | 210394 | FDA UDI | N/A | Active |
| Grifols Wash Solution B | 213683 | FDA UDI | Class I | Active |
| DG Gel 8 ABO/Rh+Kell | 210383 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-K | 210225 | FDA UDI | N/A | Active |
| DG Reader | 213779 | FDA UDI | Class II | Unknown |
| DG Gel 8 Anti-K | 210119 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-AB | 210200 | FDA UDI | N/A | Active |
| DG Gel 8 Anti-c | 210123 | FDA UDI | N/A | Unknown |
| WADiana Compact | 213789 | FDA UDI | Class II | Active |
| DG Gel 8 Anti-C | 210201 | FDA UDI | N/A | Active |
| Grifols Diluent | 213677 | FDA UDI | Class II | Active |
| DG Gel 8 ABO/Rh | 210118 | FDA UDI | N/A | Unknown |
| DG Gel 8 A/B/D | 210384 | FDA UDI | N/A | Active |
| DG Gel 8 Direct Coombs | 210129 | FDA UDI | N/A | Active |
| Blood Typing Manager | 210404 | FDA UDI | Class II | Active |
| DG Gel 8 Anti-E | 210122 | FDA UDI | N/A | Unknown |
| DG Clean | 213797 | FDA UDI | Class I | Active |
| Erytra | 210400 | FDA UDI | Class II | Active |
| DG Gel 8 AB (x4) | 210386 | FDA UDI | N/A | Active |
| DG Gel 8 Anti-c | 210226 | FDA UDI | N/A | Active |
| DG Reader Net | 210700 | FDA UDI | Class II | Active |
| DG Therm | 213734 | FDA UDI | Class II | Active |
| DG Gel 8 Rh Pheno | 210228 | FDA UDI | N/A | Active |
| DG Gel 8 Anti-D | 210202 | FDA UDI | N/A | Active |
| DG Gel 8 ABO/Rh (2D) | 210128 | FDA UDI | N/A | Active |
| Erytra Eflexis | 210600 | FDA UDI | Class II | Active |
| Erytra | 210401 | FDA UDI | Class II | Active |
| Grifols Wash Solution A | 213682 | FDA UDI | Class I | Active |
| DG Gel 8 Neutral | 210393 | FDA UDI | Class II | Active |
| DG Gel 8 Anti-D | 210120 | FDA UDI | N/A | Unknown |
| DG Gel 8 T/S Mono | 210391 | FDA UDI | N/A | Unknown |
| DG Gel 8 Anti-E | 210224 | FDA UDI | N/A | Active |
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